A Texas doctor used his GOP connections to get hydroxychloroquine to administer to dozens of elderly patients diagnosed with COVID-19 in what he calls an "observational study." In some cases, he didn't discuss with families before prescribing the drug.https://trib.al/9wF549I
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IMO the line between tracking outcomes/quality improvement and research is not always as distinct as we would like. If a surgeon adopts a ligasure for thyroidectomies, tracks OR times and bleeds, and then decides to publish them, is that research that requires a prospective IRB?
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Most would argue no- so long as the ligasure was adopted and used for the purpose of benefiting the patient, and the OR times tracked for the purpose of improving quality of care.
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